Pharmacovigilance (PV) Lead responsible for overseeing PV operations across Rhythm's clinical development and post-marketing products, ensuring high-quality safety data management.
Responsibilities include managing individual case safety reports from trials and post-marketing sources, vendor oversight through KPI monitoring and governance, and contributing to global PV documents such as PBRERs, PSURs, DSURs, and RMPs. The role supports cross-functional safety deliverables, provides input for clinical study documents, and participates in PV strategic planning, process improvements, audits, and SOP development. It also involves mentoring junior PV staff and staying current with evolving PV regulations and industry best practices.
Qualifications include a Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or Biomedical Sciences; 8+ years of PV operations experience, with 3+ years in a global post-marketing setting preferred. Expertise in global PV requirements, GxP, ICH guidelines, MedDRA, and safety databases like Argus is essential. Strong stakeholder interaction skills within matrix environments and excellent communication in English are required.
The position is based in Boston, operating under a hybrid-work model, with some travel expected. The role offers a salary range of $160,000-$240,000, with potential bonuses and benefits. The focus is on supporting Rhythm’s mission to develop medicines for rare neuroendocrine diseases, emphasizing regulatory compliance, safety monitoring, and cross-functional collaboration in a global, innovative environment.
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